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This study aims to assess the efficacy of narrow-band ultraviolet B (NB-UVB) phototherapy as a standalone treatment in patients with resistant and recurrent tinea.
To evaluate the clinical and mycological improvement in response to NB-UVB therapy compared to standard anti-fungal treatment alone.
Randomized, parallel-group, two-arm clinical trial. Arm A (NB-UVB group): Patients receive narrowband UVB phototherapy only.
Arm B (Itraconazole + Terbinafine group): Patients receive combined oral itraconazole and terbinafine.
Allocation will be 1:1 using concealed randomization.
Intervention:
Intervention (Arm A):
Patients in Arm A will receive narrowband UVB phototherapy (311 nm) three times per week for a total of 8 weeks.
Starting dose: 280-320 mJ/cm² (based on Fitzpatrick skin type)
Dose escalation: Increase by 10-20% each week as tolerated, with weekly monitoring for erythema or other adverse effects.
Follow-up: All Arm A patients will be re-evaluated clinically and mycologically 8 weeks after completing the 8-week NB-UVB course (i.e., at week 16 from baseline) to assess sustained response and relapse.
Intervention (Arm B):
Patients in Arm B will receive oral itraconazole plus terbinafine concurrently:
Itraconazole: 200 mg once daily for 8 weeks
Terbinafine: 250 mg once daily for 8 weeks
Follow-up: All Arm B patients will be re-evaluated clinically and mycologically 8 weeks after completing the 8-week antifungal course (also at week 16 from baseline) to assess sustained response and relapse.
Monitoring: Weekly observation for erythema or side effects.
A follow-up period of 8 weeks after the end of treatment will be included to assess relapse and sustained clinical/mycological improvement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NBUVB | Experimental | Type of phototherapy |
|
| Medical treatment | Active Comparator | combined oral itraconazole and terbinafine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NBUVB | Device | Phototherapy device |
| |
| Itraconazole + terbinafine |
| Measure | Description | Time Frame |
|---|---|---|
| Dermatophytosis Severity Score (DSS) | 8 weeks |
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Inclusion Criteria:
Both sexes.
Clinical diagnosis of tinea corporis or cruris.
Failure of ≥4 weeks of systemic antifungal therapy (e.g., terbinafine or itraconazole).
No antifungal (topical or systemic) or corticosteroid treatment in the 2 weeks preceding enrollment.
Recurrent infection (≥2 relapses in the past 6 months)
Positive KOH microscopy and culture at baseline
Exclusion Criteria:
Xeroderma pigmentosa, LE or other photosensitive dermatoses. dermatomyositis.
Other skin conditions (psoriasis, eczema, etc.).
Known autoimmune diseases, immunosuppression, or coagulopathies..
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| ID | Term |
|---|---|
| D017964 | Itraconazole |
| D000077291 | Terbinafine |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Drug |
Antifungal drugs |
|
| D010879 |
| Piperazines |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |